Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-01

Study Completion Date

2008-04-17

Brief Summary

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A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Subjects receiving GSK716155 + placebo

Eligible subjects will receive GSK716155 with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. Subjects will also receive placebo.

Group Type EXPERIMENTAL

GSK716155 for injection

Intervention Type DRUG

GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.

Placebo

Intervention Type DRUG

Subjects will also receive placebo.

Interventions

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GSK716155 for injection

GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.

Intervention Type DRUG

Placebo

Subjects will also receive placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus diagnosed at least 3 months with FPG level \<=240mg/dL and HbA1c between 6.5% and 10% inclusive.
* Must be diet controlled - OR - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
* Must have a BMI:\<=35kg/m2, 20 to 70 years of age inclusive.
* Woman must be of non-childbearing potential.

Exclusion Criteria

* Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
* Clinically significant hepatic enzyme elevation.
* History of metabolic disease other than T2DM.
* Previous use of insulin as a treatment for diabetes within 3 months.
* History of severe gastrointestinal disease.
* Clinically significant cardiovascular disease.
* Significant renal disease as defined by screening lab test.
* History of drug (including albumin or albumin containing agents) allergy.
* History of alcohol or drug abuse.
* Donation of blood in excess of 400mL within previous 4 months.
* Previously received any GLP-1 mimetic or any other albumin-containing products.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Fukuoka, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Seino Y, Nakajima H, Miyahara H, Kurita T, Bush MA, Yang F, Stewart MW. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin. 2009 Dec;25(12):3049-57. doi: 10.1185/03007990903372999.

Reference Type BACKGROUND

PMID: 19863477 (View on PubMed)

Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

Reference Type DERIVED

PMID: 25387217 (View on PubMed)

Study Documents

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